Allogene Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results
February 27 2020 - 4:30AM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) therapies for cancer, today provided a corporate
update and reported fourth quarter and full-year 2019 financial
results for the periods ended December 31, 2019.
"2019 was a very successful year for Allogene. We accomplished
all of our corporate goals, which includes the establishment of
world-class capabilities across multiple new functions and the
initiation of our first clinical trials in patients with relapsed
or refractory aggressive non-Hodgkin lymphoma and multiple
myeloma," said David Chang, M.D., Ph.D., President, Chief Executive
Officer and Co-Founder of Allogene. "Our momentum and focus towards
making AlloCAR T therapies and their life-saving potential a
reality for patients will continue at full speed in 2020. This year
will be an important one as we look to demonstrate proof-of-concept
data from two key programs and plan for potential pivotal
studies."
Recent Highlights
ALLO-501 (anti-CD19 AlloCAR T)
- In 2019, Allogene initiated the ALLO-501 Phase 1 ALPHA trial in
patients with relapsed/refractory non-Hodgkin lymphoma (NHL). This
study utilizes ALLO-647, Allogene's anti-CD52 monoclonal antibody
(mAb) as a part of the lymphodepletion regimen. Initial data is
planned to be presented at a medical meeting in Q2 2020.
- The U.S. Food and Drug Administration cleared the
Investigational New Drug Application (IND) for ALLO-501A, the
Company’s next generation anti-CD19 AlloCAR T construct devoid of
the rituximab off-switch. ALLO-501A, previously referred to as
ALLO-501.1, was created to eliminate the rituximab recognition
domains in ALLO-501, allowing for use in a broader patient
population, including those NHL patients with recent rituximab
exposure.
- The Company expects to initiate an abbreviated Phase 1 portion
of the ALLO-501A trial (ALPHA2) in the second quarter of the year.
The ALPHA2 trial will leverage the findings of the ALPHA trial to
finalize the ALLO-501A cell dose and the ALLO-647 based
lymphodepletion regimen for a potential pivotal Phase 2 trial.
ALLO-715 (anti-BCMA AlloCAR T)
- The Company has created a robust anti-BCMA strategy centered
around ALLO-715 for the treatment of multiple myeloma (MM).
- In 2019, Allogene initiated the ALLO-715 Phase 1 UNIVERSAL
trial in patients with relapsed/refractory MM, designed to assess
the safety and tolerability of ALLO-715. This trial is also
intended to identify the optimal dose of ALLO-647 and includes the
potential to evaluate lymphodepletion regimens that do not include
fludarabine and cyclophosphamide. UNIVERSAL continues to accrue as
planned with initial data anticipated in Q4 2020.
- In January 2020, Allogene entered into a clinical collaboration
with SpringWorks Therapeutics to evaluate ALLO-715 in combination
with SpringWorks’ investigational gamma secretase inhibitor,
nirogacestat, in patients with relapsed/refractory MM. The Company
expects to initiate this combination trial in the second half of
2020.
- The Company nominated ALLO-605 as its first TurboCARTM
candidate and part of its larger MM strategy. The TurboCAR
technology provides the effects of cytokine stimulation to AlloCAR
T cells with the goal of enhancing their potency, expansion and
persistence. ALLO-605 is advancing in preclinical development with
a potential IND in 2021.
Additional Pipeline
Updates
- The Company nominated ALLO-316, an anti-CD70 AlloCAR T, as its
next clinical candidate for potential development in acute myeloid
leukemia, T-cell malignancies and/or renal cell carcinoma.
Submission of the IND for ALLO-316 is expected by year end
2020.
Fourth Quarter Financial Results
- As of December 31, 2019, Allogene had $588.9 million in cash,
cash equivalents, and investments.
- Research and development expenses were $49.4 million for the
fourth quarter of 2019, which includes $6.4 million of non-cash
stock-based compensation expense and $10.0 million in expenses
associated with the signing of our collaboration with Notch
Therapeutics. For the full year of 2019, research and development
expenses were $144.5 million. Research and development expense for
the year includes $19.4 million of non-cash stock-based
compensation expense.
- General and administrative expenses were $15.2 million for the
fourth quarter of 2019, which includes $7.5 million of non-cash
stock-based compensation expense. For the full year of 2019,
general and administrative expenses were $57.5 million, which
includes $26.6 million of non-cash stock-based compensation
expense.
- Net loss for the fourth quarter of 2019 was $61.0 million, or
$0.58 per share, including non-cash stock-based compensation
expense of $13.9 million. For the full year of 2019, our net loss
was $184.6 million, or $1.83 per share, including non-cash
stock-based compensation expense of $46.1 million.
2020 Financial Guidance
- Allogene expects full year GAAP net losses to be between $260
million and $280 million including estimated non-cash stock-based
compensation expense of $70 million to $75 million and excluding
any impact from potential business development activities.
Conference Call and Webcast DetailsAllogene
will host a live conference call and webcast today at 5:30 a.m.
Pacific Time / 8:30 a.m. Eastern Time to discuss financial results
and provide a business update. To access the live conference call
by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409)
216-0618 (International). The conference ID number for the live
call is 2981059. The webcast will be made available on the
Company's website at www.allogene.com under the Investors tab in
the News and Events section. Following the live audio webcast, a
replay will be available on the Company's website for approximately
30 days.
About Allogene TherapeuticsAllogene
Therapeutics, with headquarters in South San Francisco, is a
clinical-stage biotechnology company pioneering the development of
allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies
for cancer. Led by a world-class management team with significant
experience in cell therapy, Allogene is developing a pipeline of
“off-the-shelf” CAR T cell therapy candidates with the goal of
delivering readily available cell therapy on-demand, more reliably,
and at greater scale to more patients. For more information, please
visit www.allogene.com, and follow @AllogeneTx on Twitter and
LinkedIn.
Cautionary Note on Forward-Looking
Statements This press release contains
forward-looking statements for purposes of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
The press release may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could,"
"might," "will," "should" or other words that convey uncertainty of
future events or outcomes to identify these forward-looking
statements. Forward-looking statements include statements regarding
intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things: the timing and ability
to progress the clinical trials of ALLO-501 and ALLO-715 and
present any proof-of-concept data from the trials, the timing and
ability to initiate and progress a clinical trial of ALLO-501A, our
collaborator’s ability to obtain any necessary rights to ALLO-501A,
the timing and ability to initiate a clinical trial of ALLO-715 in
combination with SpringWorks’ nirogacestat, the timing and ability
to file an IND and initiate clinical trials of ALLO-316 and
ALLO-605, the ability to manufacture AlloCAR T™ therapies,
including ALLO-501A, ALLO-316 and ALLO-605 for use in clinical
trials, the potential benefits of AlloCAR T™ therapy and the 2020
financial guidance. Various factors may cause differences between
Allogene’s expectations and actual results as discussed in greater
detail in Allogene’s filings with the Securities and Exchange
Commission (SEC), including without limitation in its Form 10-Q for
the quarter ended September 30, 2019. Any forward-looking
statements that are made in this press release speak only as of the
date of this press release. Allogene assumes no obligation to
update the forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
ALLOGENE THERAPEUTICS, INC. SELECTED FINANCIAL
DATA(unaudited; in thousands, except share and per share
data)
STATEMENTS OF OPERATIONS
|
Three Months EndedDecember 31, |
|
Year Ended December 31, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
49,363 |
|
|
|
$ |
18,503 |
|
|
|
$ |
144,535 |
|
|
|
$ |
151,860 |
|
|
General and administrative |
15,212 |
|
|
|
14,543 |
|
|
|
57,473 |
|
|
|
40,982 |
|
|
Total operating expenses |
64,575 |
|
|
|
33,046 |
|
|
|
202,008 |
|
|
|
192,842 |
|
|
Loss from operations |
(64,575 |
) |
|
|
(33,046 |
) |
|
|
(202,008 |
) |
|
|
(192,842 |
) |
|
Other income (expense),
net: |
|
|
|
|
|
|
|
Change in fair value of convertible note payable |
— |
|
|
|
(1,796 |
) |
|
|
— |
|
|
|
(19,415 |
) |
|
Interest expense |
— |
|
|
|
— |
|
|
|
— |
|
|
|
(3,358 |
) |
|
Interest and other income, net |
3,658 |
|
|
|
4,216 |
|
|
|
17,351 |
|
|
|
1,573 |
|
|
Other expenses |
(268 |
) |
|
|
— |
|
|
|
(268 |
) |
|
|
— |
|
|
Loss before income taxes |
(61,185 |
) |
|
|
(30,626 |
) |
|
|
(184,925 |
) |
|
|
(211,622 |
) |
|
Benefit from income taxes |
155 |
|
|
|
117 |
|
|
|
331 |
|
|
|
117 |
|
|
Net loss |
(61,030 |
) |
|
|
(30,509 |
) |
|
|
(184,594 |
) |
|
|
(211,505 |
) |
|
Net loss per share, basic and
diluted |
$ |
(0.58 |
) |
|
|
$ |
(0.37 |
) |
|
|
$ |
(1.83 |
) |
|
|
$ |
(7.31 |
) |
|
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
104,800,502 |
|
|
|
82,064,497 |
|
|
|
101,061,149 |
|
|
|
28,948,386 |
|
|
SELECTED BALANCE SHEET DATA
|
As of December 31,2019 |
|
As of December 31,2018 |
Cash, cash equivalents and investments |
$ |
588,855 |
|
|
$ |
721,350 |
|
Total assets |
717,802 |
|
|
773,855 |
|
Total liabilities |
88,779 |
|
|
70,691 |
|
Total stockholders’
equity |
629,023 |
|
|
703,164 |
|
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
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